3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
US antivirals giant Gilead Sciences today announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six generic drugmakers to make and sell generic lenacapavir 2 October 2024
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. 2 October 2024
The number of clinical trials of new drugs in Russia is steadily declining, which could be mainly related with the overall reduction of investment activities in the local pharmaceutical market, reports The Pharma Letter’s local correspondent. 30 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. 9 September 2024
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
German generics major STADA Arzneimittel today announced that it achieved sales of more than 2 billion euros ($2.23 billion) in the first half of 2024. 28 August 2024
In a major crackdown, the Indian government has imposed an immediate ban on 156 fixed-dose combination (FDC) drugs, including commonly used antibiotics, pain relievers,and multivitamins. 27 August 2024
Swipha, a leading Nigerian pharmaceutical manufacturer, has received prequalification from the World Health Organization (WHO) for its sulfadoxine-pyrimethamine (SP) drug. 21 August 2024
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
Even as Novartis (NOVN: VX) is locked in a high-stakes battle with the US Food and Drug Administration (FDA) to protect its blockbuster heart failure drug Entresto (sacubitril and valsartan) from generic competition, generic versions of valsartan are making hay in India 8 August 2024
The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk. 8 August 2024
US biotech major Biogen is disputing the launch of a Russian generic of Spinraza (nusinersen), a drug, which is used to treat spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent. 7 August 2024
Imports of bulk drugs from China have jumped, potentially undermining India's efforts to boost domestic pharmaceutical manufacturing through its Production Linked Incentive (PLI) scheme. 5 August 2024
Indian drug major Lupin has entered into a definitive agreement with Polish drugmaker Celon Pharma to develop fluticasone/salmeterol dry powder inhaler (DPI) product which is a generic version of GlaxoSmithKline's blockbuster respiratory drug Advair Diskus. 18 February 2015
Ireland-headquartered generics major Actavis yesterday confirmed that the US Court of Appeals for the Federal Circuit has issued a temporary injunction to prevent Actavis from further distribution of its generic version of Pulmicort Respules (budesonide inhalation suspension pending its consideration of AstraZeneca's request for an injunction pending appeal. 18 February 2015
Israeli generic giant Teva Pharmaceutical Industries has launched a generic equivalent of French pharma major Sanofi’s Lovenox (enoxaparin sodium injection) in seven dosage strengths in the USA. 17 February 2015
The Russian government plans to provide subsidies for the production of pharmaceutical substances for leading national drugmakers this year, according to Alexander Petrov, member of the Committee on Health of the Russian State Duma. 16 February 2015
Ireland-based generic drugs major Actavis has launched its generic version of Anglo-Swedish pharma major AstraZeneca's Pulmicort Respules (budesonide inhalation suspension). 14 February 2015
Ireland-headquartered generics major Actavis has reached a definitive agreement with TPG, the global private investment firm, to divest to TPG the business currently known as Aptalis Pharmaceutical Technologies (Pharmatech). 13 February 2015
Julphar, the largest Emirati pharmaceutical company, has acquired a majority stake in Bangladesh drugmaker RAK Pharmaceuticals for $9.5 million, marking its entry into the region and an expansion of its footprint in Asia. 13 February 2015
US drugmaker Hospira, a leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, today reported results for the fourth quarter and full-year 2014. 12 February 2015
Privately-held US generic drugmaker Breckenridge Pharmaceutical has filed an Abbreviated New Drug Application with the US Food and drug administration, with a Paragraph IV certification for cabazitaxel solution; IV (infusion), a generic version of French pharma major Sanofi’s cancer drug Jevtana. 12 February 2015
US generics drugmaker Mylan has confirmed that it has been sued by German pharma major Bayer and partner Onyx Pharmaceuticals (a subsidiary of Amgen), in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for sorafenib. 10 February 2015
Ireland-headquartered generics major Actavis has entered an agreement with Mayne Pharma to divest the US rights to the Doryx (doxycycline) brand acne treatment and related assets. 10 February 2015
The US Food and Drug Administration has issued yet another warning letter to Canada-headquartered generics drugmaker Apotex, regarding its Bangalore-based Apotex Research Private unit, citing serious manufacturing violations. 9 February 2015
The Russian government may consider the possibility of the re-purchase of the Russian pharmaceutical producer Veropharm that was recently acquired by the US drugmaker Abbott. 9 February 2015
Stiff competition from China is undermining the Indian bulk drug industry. While imports from China are growing at over 30%, Indian exporters maintain that it is difficult to crack the Chinese market, reports The Pharma Letter’s India correspondent. 8 February 2015
US drugmaker Cambrex has initiated the second significant expansion of its Charles City, Iowa, facility in less than three years. Strong continued growth in demand for the company's active pharmaceutical ingredient (API) contract manufacturing capabilities is driving the need for more capacity. 6 February 2015
Sweden-based pharma company Orexo has filed a patent infringement law suit in the US District Court for New Jersey against Ireland-headquartered generics major Actavis. 6 February 2015
Israel-based Teva Pharmaceutical Industries today reported results for the quarter and the year ended December 31, 2014, which were in line with analysts’ forecasts. 5 February 2015
The French pharmaceutical market is forecast to grow at a tepid compound annual growth rate (CAGR) of 0.7% from $46.2 billion in 2014 to $48.2 billion by 2020, restricted by an increasing focus on generic drugs, according to a new study. 4 February 2015
US generics drugmaker Mylan has signed a definitive agreement to acquire certain female health care businesses from India’s Famy Care Limited, a specialty women's health care company with global leadership in generic oral contraceptive products (OCPs). 2 February 2015
Indian drugmakers Sun Pharmaceutical Industries Ltd. and Ranbaxy Laboratories have agreed to divest Ranbaxy’s interests in generic minocycline tablets in order to settle US Federal Trade Commission charges that Sun’s $4 billion proposed acquisition of Ranbaxy would likely be anticompetitive. 1 February 2015
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A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.